IEC 62353-ed.2.0

Podrobné informace

Označení: IEC 62353-ed.2.0

Datum vydání: 04.09.2014

Stran: 129

Země: Mezinárodní technická norma

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Anotace

IEC 62353:2014 applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition) and its amendments, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such ME equipment or ME systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. This standard contains "general requirements", which contain clauses of general concern, and "particular requirements", further clauses handling special types of ME equipment or ME systems and applying in connection with the "General requirements". This standard is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design. This standard is not applicable to the assembly of ME systems. For assembling ME systems see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems. All maintenance, inspection, servicing, and repair done in accordance with the manufacturers instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. This standard is also applicable to tests after repair. This second edition cancels and replaces the first edition of IEC 62353 published in 2007. This edition constitutes a technical revision including the following main revisions: - clarification in 5.3.4.1 that measurements of leakage currents based on test configurations derived from IEC 60601-1 are an allowable alternative method and the inclusion of informative explanation in Annex A; - revision of the protective earth resistance requirements for ME systems using multiple socket outlets to take account of IEC 60601-1:2005/AMD1:2012 on the safe allowed values of protective earth resistance of plugged-in equipment; - the inclusion of expected minimum insulation resistance values in Table 2; and - a reordering of the sequence of testing in Annex B. LIEC 62353:2014 sapplique aux essais des appareils electromedicaux et des systemes electromedicaux, ci-apres denommes appareils EM et systemes EM, ou des parties de ces appareils ou systemes, conformes a lIEC 60601-1:1988 (deuxieme edition) et a ses amendements et a lIEC 60601-1:2005 (troisieme edition) et a ses amendements, avant leur mise en service, pendant la maintenance, linspection, lentretien courant et apres leur reparation ou a loccasion dessais recurrents afin devaluer la securite de ces appareils EM ou systemes EM ou de leurs parties. Pour les appareils non construits conformement a lIEC 60601-1, ces exigences peuvent etre utilisees en tenant compte des normes de securite pour la conception et les informations contenues dans les instructions dutilisation de ces appareils. La presente norme comprend des tableaux donnant des valeurs admissibles se rapportant aux differentes editions de lIEC 60601-1. Pour les besoins de la presente norme, lapplication des methodes de mesure est independante de ledition selon laquelle les appareils EM ou les systemes EM sont concus. La presente norme comprend des "exigences generales", contenant des articles de portee generale, et des "exigences particulieres", dautres articles traitant de types speciaux dappareils EM ou de systemes EM et sappliquant en conjonction avec les "exigences generales". La presente norme nest pas appropriee pour evaluer si des appareils EM ou des systemes EM ou dautres appareils satisfont ou non aux normes correspondantes relatives a leur conception. La presente norme ne sapplique pas a lassemblage des systemes EM. Pour lassemblage des systemes EM, voir lArticle 16 de lIEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. La presente norme ne definit pas dexigence pour la reparation, lechange des composants et la modification des appareils EM ou des systemes EM. Toutes les operations de maintenance, inspection, entretien courant et reparation effectuees conformement aux instructions du fabricant conservent la conformite a la norme utilisee pour la conception de lappareil. Sinon, il convient devaluer et de verifier la conformite aux exigences applicables avant deffectuer les essais de la presente norme. La presente norme sapplique egalement aux essais apres reparation. Cette deuxieme edition annule et remplace la premiere edition de lIEC 62353 parue en 2007. Cette edition constitue une revision technique qui contient les principales modifications suivantes: - clarification en 5.3.4.1 que les mesurages des courants de fuite sur la base des configurations dessai derivees de lIEC 60601-1 representent une autre methode acceptable, et ajout dexplications informatives en Annexe A; - revision des exigences relatives a la resistance de terre de protection pour les systemes EM utilisant des socles de prises multiples, de facon a prendre en compte lIEC 60601-1 Amendement 1 concernant les valeurs admises sures de la resistance de terre de protection des appareils branches; - ajout des valeurs minimales attendues de la resistance disolement dans le Tableau 2; - et nouvel ordre pour la sequence des essais en Annexe B. La version francaise de cette norme na pas ete soumise au vote.